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FDA To Provide Expedited Approval Desktop Reference

 
• By Derrick Gingery

Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.

FDA expects to write one comprehensive guidance explaining its expedited approval programs to eliminate confusion and more easily meet some of the requirements of new user fee legislation.

In addition to explaining new pathways, like the breakthrough therapy designation, the guidance will serve as a desktop reference guide of sorts – more clearly defining the

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